Ingredient record · Anti-gas agent
Simethicone: bans, restrictions and failed batches in India
Last checked 20 September 2026. Sources: CDSCO banned-drugs notifications and monthly NSQ alerts, Jan 2019 to Jul 2026
14 entries containing Simethicone are on India's banned-drugs list, and 8 are banned today. 24 batches of medicines containing Simethicone failed a government lab test between March 2019 and July 2026, from 18 manufacturers. A failed batch concerns that batch only, not the medicine or every brand.
8
Banned combinations in force
6
Other listed orders (stayed, restricted, quashed)
24
Batches failed a lab test
Jul 2026
Latest lab alert
Is it banned? Our answer pages
Not banned · gel batches recalled (2023)
Not banned · some combos banned
On the banned-drugs list
Simethicone on its own is not on CDSCO's banned list. The entries below are specific combinations that contain it. Status follows CDSCO's own notes on each entry.
| Drug / combination | Action | Notification | Date | Order | Status note |
|---|---|---|---|---|---|
| Aluminium Hydroxide 365mg + Magnesium Hydroxide 80mg + Simethicone 100mg + Deglycyrrhizinated Liquorice 400mg per 5ml Oral SuspensionFixed-dose combination · gi | Halted | CDSCO F.No. 4-01/2023-DC (Misc. 3) dated 11.04.2025, Annexure Sr. 9 | 11 April 2025 | 35 FDCs · Apr 2025 | CDSCO direction to state licensing authorities, 11 Apr 2025, not a Section 26A gazette ban |
| Norfloxacin 125mg + Metronidazole 120mg + Simethicone 10mg SuspensionFixed-dose combination · antibiotics | Halted | CDSCO F.No. 4-01/2023-DC (Misc. 3) dated 11.04.2025, Annexure Sr. 26 | 11 April 2025 | 35 FDCs · Apr 2025 | CDSCO direction to state licensing authorities, 11 Apr 2025, not a Section 26A gazette ban |
| Sucralfate + Domperidone + SimethiconeFixed-dose combination · gi | Banned | S.O. 3437(E) | 2 August 2024 | 156 FDCs · Aug 2024 | Prohibited under s.26A; notifications dated 02.08.2024, gazetted 21-22 Aug 2024. |
| Dicyclomine + Paracetamol + SimethiconeFixed-dose combination · gi | Banned | S.O. 221(E) | 11 January 2019 | Other orders | One of 80 FDCs prohibited vide S.O. 180(E)-259(E) dated 11.01.2019 (CDSCO letter 22.01.2019). In force per CDSCO list as on 22.11.2021. |
| Ranitidine + Dicycloverine + SimethiconeFixed-dose combination · gi | Banned | S.O. 250(E) | 11 January 2019 | Other orders | One of 80 FDCs prohibited vide S.O. 180(E)-259(E) dated 11.01.2019 (CDSCO letter 22.01.2019). In force per CDSCO list as on 22.11.2021. |
| Magaldrat + Famotidine + SimethiconeFixed-dose combination · gi | Banned | S.O. 4497(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Ranitidine + Magaldrate + SimethiconeFixed-dose combination · gi | Banned | S.O. 4500(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Magaldrate + Papain + Fungal Diastase + SimethiconeFixed-dose combination · gi | Banned | S.O. 4501(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Ranitidine + Domperidone + SimethiconeFixed-dose combination · gi | Banned | S.O. 4504(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Zinc Carnosine + Magnesium Hydroxide + Dried Aluminium Hydroxide + SimethiconeFixed-dose combination · gi | Banned | S.O. 4514(E) | 7 September 2018 | 328 FDCs · Sep 2018 | In force per CDSCO list as on 22.11.2021 |
| Magaldrate + Famotidine + SimethiconeFixed-dose combination · gi | Quashed | S.O. 834(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Ranitidine + Magaldrate + SimethiconeFixed-dose combination · gi | Quashed | S.O. 837(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Magaldrate + Papain + Fungul Diastase + SimethiconeFixed-dose combination · gi | Quashed | S.O. 838(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
| Zinc Carnosine + Magnesiumhydroxide + Dried Aluminium Hydroxide + SimethiconeFixed-dose combination · gi | Quashed | S.O. 851(E) | 10 March 2016 | 344 FDCs · Mar 2016 | Quashed by Delhi HC 1 Dec 2016; see 2018 re-ban |
Products that failed lab tests
Product names as printed by the testing labs, grouped. Open a product to see every batch number.
| Product | Batches | Makers | Latest |
|---|---|---|---|
| Disilox Mps | 4 | 1 | Dec 2021 |
| Aluminium Hydroxide Magnesium Simethicone | 3 | 3 | Jan 2026 |
| Alumina Magnesia Simethicone | 3 | 2 | Sep 2022 |
| Ofloxacin Metronidazole Simethicone | 2 | 2 | Jul 2026 |
| Simethicone | 2 | 2 | Jun 2026 |
| Aluminium Magnesium Simethicone | 2 | 2 | Nov 2025 |
| Dried Aluminium Hydroxide Magnesium Simethicone | 2 | 2 | Nov 2025 |
| Aluminum Hydroxide Simethicone Magnesium | 1 | 1 | Sep 2024 |
| Dynacid | 1 | 1 | Jun 2024 |
| Betacid | 1 | 1 | Apr 2023 |
| Alusil | 1 | 1 | Jun 2021 |
| Ulgel A | 1 | 1 | Feb 2021 |
| Alumina Magnesium Hydroxide Carbonate Simethicone Milucid | 1 | 1 | Mar 2019 |
Most recent failed batches
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| Ofloxacin Metronidazole and Simethicone Suspension | OXG2501Mfg 2025-09 · Exp 2027-08 | Apple Formulations Pvt. LtdUttarakhand | Content of Metronidazole (45.68%)Other | Drugs Testing Laboratory, Madurai-19State lab | Jul 2026 |
| Simethicone Drops 30ml | EH25057Mfg 2025-11 · Exp 2028-10 | Priya Life ScienceGujarat | The sample does not conform to Manufacturers specification with respect to test for pH and Assay.Assay | CDTL, MumbaiCDSCO lab | Jun 2026 |
| Ofloxacin, Metronidazole & Simethicone Suspension | ZRSL - 1533Mfg 2025-06 · Exp 2027-05 | ZRS Pharmaceuticals India Pvt. LtdHimachal Pradesh | The sample does not conform to claim as per Patent and Proprietary in respect to the Assay of Ofloxacin.Assay | RDTL, ChandigarhCDSCO lab | Jan 2026 |
| Aluminium Hydroxide, Magnesium Hydroxide & Simethicone Oral Suspension IP | PL-40143Mfg 2024-06 · Exp 2026-05 | Pharmaroots HealthcareHimachal Pradesh | Content and Microbial LimitMicrobial limits | Drugs Testing Laboratory, Chennai-06State lab | Jan 2026 |
| Simethicone Oral Suspension U.S.P | 1503Mfg 2025-03 · Exp 2027-02 | Pulse Pharma MFG. CoGujarat | ContentOther | Drugs Testing Laboratory, Chennai-06State lab | Nov 2025 |
| Dried Aluminium Hydroxide Gel, Magnesium Hydroxide and Simethicone Suspension IP | ECL/25/146Mfg 2025-06 · Exp 2027-05 | Emmchak Formulations Pvt. Ltd | ContentOther | Drugs Testing Laboratory, Chennai-06State lab | Nov 2025 |
| Aluminium, Magnesium and Simethicone Oral Suspension IP | L25/0172AMfg 2025-06 · Exp 2027-05 | SamkemMadhya Pradesh | General DescriptionDescription | Drugs Testing Laboratory, Chennai-06State lab | Nov 2025 |
| Aluminium Hydroxide, Magnesium Hydroxide and Simethicone Oral Suspension IP | ECL/25/026Mfg 2025-04 · Exp 2027-03 | Emmchak Formulations Pvt. Ltd | ContentOther | Drugs Testing Laboratory, Chennai-06State lab | Nov 2025 |
| Aluminium, Magnesium &Simethicone Oral Suspension I.P | C21A133003Mfg 2023-06 · Exp 2026-05 | Concept Pharmaceuticals Ltd | Description onlyDescription | State Lab KarnatakaState lab | Dec 2024 |
| Aluminum Hydroxide, Simethicone & Magnesium Hydroxide Suspension (Spisam Gel) | L22455Mfg 2022-12 · Exp 2024-11 | Aan Pharma Private LimitedGujarat | Assay / Content of Magnesium Hydroxide, Simethicone and Aluminium Hydroxide gelAssay | CDTL MumbaiCDSCO lab | Sep 2024 |
| DYNACID SUSPENSION (aluminium, magnesium & simethicone oral suspension IP.) | BULH23008Mfg 2023-04 · Exp 2025-03 | Leeford Healthcare Ltd | 1) THE SAMPLE DOES NOT COMPLY WITH I.P. REQUIREMENTS FOR TOTAL AEROBIC VIABLE COUNT IN TEST FOR MICROBIAL CONTAMINATION. 2) TOTAL AEROBIC VIABLE COUNT OF THE SAMPLE IS 20993128 CFU/GM. (1.P. LIMIT-TOTAL AEROBIC VIABLE COUNT OF THE SAMPLE - NOT MORE THAN 100 CFU/GMMicrobial limits | State Lab MaharashtraState lab | Jun 2024 |
| Simethicone, Aluminium Hydroxide and Magnesium Hydroxide Suspension (Gastro-Gel Antacid) | 8881Mfg 2021-10 · Exp 2023-09 | Ramson RemediesPunjab | Description and pHDescription | RDTL ChandigarhState lab | Sep 2023 |
| BETACID (Aluminia, Magnesia and Simethicone Oral Suspension U.S.P.) | BC-10222Mfg 2022-10 · Exp 2024-09 | Alapati PharmaAndhra Pradesh | Assay of Polydimethyl -siloxaneAssay | CDL KolkataCDSCO lab | Apr 2023 |
| Alumina, Magnesia & Simethicone Tablets U.S.P. | 2718Mfg 2021-12 · Exp 2023-11 | Abicee Pharmaceuticals Pvt. LtdOdisha | Assay of SimethiconeAssay | CDL KolkataCDSCO lab | Sep 2022 |
| Disilox MPS (Aluminium, Magnesium and Simethicone Oral Suspension I.P.) | C22C105Mfg 2021-06 · Exp 2024-05 | Stadmed Private LimitedWest Bengal | Microbial contaminatio n in total aerobic viable count and presence of pathogens (E.coli.)Microbial limits | CDTL MumbaiCDSCO lab | Dec 2021 |
Showing 15 of 24 records
Holding a strip or bottle? The batch number is printed after "B. No." Check it against every alert. If it matches, return it to the pharmacy. What the labels mean: status guide.